FDAFDA · Alimentos y medicamentos·N.º oficial Z-0349-2014
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
Publicado el 27 de noviembre de 2013 · Inicio del retiro: 15 de marzo de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion: 1) Cassette Check - D; 2) Cassette Check - P; 3) Proximal Occlusion; 4) Distal Occlusion; 5) Pressure Calibration Error; 6) Bad Pressure Sensor Event; 7) Bad Pressure State; 8) Distal Pressure is Out of Range; 9) Proximal Sensor is Out of Range. A pump with this issue may, instead of reporting an error, not detected occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Hospira Inc.
- Distribuidor
- Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.
- Lote
- *** 1) List Number 13000, Serial Numbers: 98121336 , 98121173 , 98120835 , 98120730 , 98120768 , 98120782 , 98120788 , 98120822 , 98120824 , 98120839 , 98120856 , 98120880 , 98120885 , 98120895 , 98120915 , 98120749 , 98120769 , 98120774 , 98120784 , 98120859 , 98120884 , 98121019 , 98121066 , 98121079 , 98121083 , 98121135 , 98121153 , 98121163 , 98121197 , 98120522 , 98120653 , 13431222 , 98120635 , 98120405 , 98120508 , 98120634 , 98121147 , 98120543 , 12470380 , 98120512 , 98120815 , 98120681 , 97971490 , 97970893 , 97970240 , 98070264 , 98070295 , 99170068 , 99170032 , 98070345 , 98070476 , 98070905 , 98070995 , 97972107 , 97972609 , 97971538 , 98021653 , 98021821 , 99400401 , 99400435 , 97970456 , 13431303 , 98021816 , 97972825 , 98021121 , 97971767 , 99107521 , 98020395 , 14180727 , 98120459 , 98120495 , 98120777 , 98020964 , 98070286 , 98121157 , 97972571 , 97970541 , 97971254 , 98120535 , 98120640 , 98120840 , 97970194 , 98021636 , 98020575 , 97972639 , 99222573 , 98021550 , 98021603 , 98021682 , 98370030 , 98020523 , 98020446 , 98020441 , 99107526 , 97971754 , 98020929 , 98020932 , 98022223 , 13434785 , 98020072 , 98020317 , 98021476 , 98021478 , 98021732 , 98021891 , 98021912 , 98021252 , 99170080 , 98020623 , 98020018 , 98020293 , 98020574 , 98021031 , 98021423 , 98021449 , 98020013 , 97972018 , 98021177 , 98020264 , 99221974 , 98020817 , 98021687 , 98070125 , 98021304 , 98021546 , 98022039 , 98020281 , 97972802 , 97972086 , 97971122 , 12470492 , 98121130 , 97972659 , 97972489 , 98120869 , 13433080 , 97972047 , 97972824 , 98020549 , 98021584 , 97970313 , 97970073 , 98021364 , 98020312 , 98021961 , 98020127 , 98020606 , 98021194 , 99222658 , 98020490 , 98021141 , 98021276 , 98021171 , 98020460 , 98021969 , 99107535 , 99221815 , 98021977 , 98021120 , 98021412 , 99222620 , 14180122 , 99400456 , 98071220 , 98070607 , 98070371 , 98070781 , 98070815 , 98070696 , 98070812 , 97972981 , 97970766 , 98020074 , 98020902 , 14180174 , 99219028 , 98070190 , 13433667 , 97970613 , 98021101 , 98021099 , 97970666 , 97970308 , 97970071 , 98021367 , 98021508 , 98021308 , 98021309 , 98021208 , 97972842 , 97972841 , 99222510 , 98020727 , 98020235 , 98021264 , 98021708 , 98021794 , 97971750 , 99170302 , 98070212 , 98070006 , 97972808 , 98021554 , 98021900 , 99400482 , 98020054 , 98021195 , 98021496 , 98120534 , 98020866 , 98021179 , 98070850 , 98070448 , 98070794 , 97972040 , 97971807 , 98350110 , 97971723 , 98350105 , 98350089 , 98021587 , 98021999 , 98021207 , 98021968 , 98020855 , 98021551 , 99400235 , 98070699 , 97972950 , 99222016 , 98070351 , 97971659 , 98020901 , 98020949 , 98020474 , 98021592 , 98021932 , 97971790 , 97971766 , 97972867 , 97972283 , 13432084 , 99170140 , 98070868 , 98070028 , 98070717 , 98070296 , 98070688 , 99220393 , 98121080 , 12474733 , 99222601 , 97971952 , 99222578 , 98121160 , 97970769 , 97970839 , 99222563 , 99222322 , 97970124 , 97972801 , 13430060 , 14180300 , 99221044 , 97972664 , 97970952 , 97970873 , 13430773 , 97972475 , 97972824 , 13431359 , 12471354 , 99221849 , 99221798 , 98120493 , 98120726 , 98120696 , 99222537 , 99220861 , 13432293 , 13434708 , 97970948 , 14180791 , 13433680 , 13431566 , 13431924 , 99222636 , 99222656 , 12474581 , 13433821 , 12474354 , 12471791 , 13433340 , 13432931 , 13431284 , 13440709 , 13433382 , 99221243 , 13433983 , 97971063 , 97971874 , 99222356 , 99221852 , 14180397 , 1343
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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